VIDEO: Review of Lyme disease treatment leaves out patients

Lyme disease patients speak out on the dangers of having the disease go undetected for an extended period of time.
Alex H. Wagner/Poughkeepsie Journal

Advocates for patients protested Lyme disease treatment guidelines April 30 and May 1 outside the headquarters of the Infectious Diseases Society of America headquarters in Arlington, Virginia. The IDSA and two other medical societies are rewriting controversial guidelines for care.(Photo: Provided by the MayDay Project)

Story Highlights

At the heart of the Lyme disease controversy is whether the Lyme infection can sometimes be chronic.

Patient advocates see an effort to affirm current guidelines in a process that shuts them out.

'If not treated early, people can become devastatingly ill,' said a critic of Lyme care guidelines.

In response to critics, officials vow to 'make adjustments to the project plan and panel.'

She comes from a state with fewer than 10 Lyme disease cases a year. She has not been involved in Lyme disease causes, but rather in funding cancer research.

Yet she has been named "consumer representative" on a panel that will rewrite treatment guidelines for a tick-borne illness with 20,000 reported cases in the mid-Hudson Valley from 2007 to 2013 — and 300,000 nationwide annually. This while federal standards say the panel should include not one but two people to represent the public: "a current or former patient and a patient advocate."

As it stands now, it has neither.

Lyme patient advocates — who want to play a role in charting the future of Lyme care — do not fault Jane Rips of Omaha, Nebraska, who has been assigned to a review of 2006 Lyme-care guidelines of the Infectious Diseases Society of America. They have even declined to name her in web posts, including one that called her appointment "deeply troubling."

Rips, wrote Lorraine Johnson, executive director of the nonprofit advocacy group Lymedisease.org, "advised us that she knows nothing about Lyme." Johnson, a leading patient advocate who has authored several journal articles on the politics and management of Lyme disease, herself was rejected for the 30-member panel, she said.

Jane Rips, who has helped raise money for cancer research in Nebraska, was named “consumer representative” on a panel that will review Lyme disease treatment guidelines. Nebraska has few Lyme cases, and Rips is not known to have any direct connection to the disease.(Photo: Provided by University of Nebraska Medical Center)

The Infectious Diseases Society has vowed to "make every effort" toward a process that is transparent and fair — one that will determine how thousands of doctors worldwide treat Lyme disease. In a statement for this article, society officials said Rips was picked "for her many years of experience in providing a consumer perspective on health care issues;" they declined to answer other questions on her appointment. However, in a May 22 letter to a five-member Lyme congressional caucus, officials said her specific lack of experience with the disease would allow her "to approach this topic objectively."

The letter was provided shortly before publication of this article by Rep. Chris Gibson, a Columbia County Republican who has advocated for better Lyme disease care. Gibson's caucus, along with dozens of Lyme groups, had criticized who was and wasn't on the panel. Signed by the presidents of the three medical societies overseeing the guidelines review, the letter defended Rips' choice while also saying the panel would be changed to include "a current or former patient and a parent of a patient who has had Lyme disease."

"We're presently working on identifying these individuals," the letter said.

While patient representatives are a key demand, the belated additions are unlikely to satisfy patient advocates. They see Rips' appointment — and many others — as part of an effort to reaffirm existing treatment recommendations, which are based largely on studies by leading society members and which represent work to which many have devoted their careers. The advocates fault the guidelines as overstating the ability to diagnose and treat the disease, therefore fostering a false sense of security among front-line doctors. And they want to be part of rewriting them.

Indeed, a Journal review of the panel's composition suggests the voices will not be heard of doctors who specialize in treating Lyme outside of the current guidelines and published scientists whose research diverges from mainstream findings.

Lyme doc omitted

The guidelines update is being managed by the disease society, known as the IDSA, and medical societies composed of neurologists and rheumatologists, who often treat Lyme symptoms. In all, 11 medical societies are represented on the panel; however, no members were appointed from the International Lyme and Associated Diseases Society, or ILADS, the leading tick-borne diseases medical group.

"There's a great divide in the United States between the IDSA and the ILADS group," said Dr. Brian Fallon, a Columbia University Lyme disease researcher who has challenged the prevailing guidelines. "Wouldn't it be a wonderful thing if there was a representative of the ILADS group?"

In 2014, ILADS, which has a few hundred members compared to the IDSA's 9,000, updated its own Lyme treatment guidelines. Its review panel was small — involving a patient advocate, physician and physician/researcher — and did not include anyone from the disease society. However, the resulting guidelines were sent to 14 outside reviewers before being submitted to an independent journal, a statement from the tick-borne society said, which in turn sent it to 12 reviewers of its choice. The reviewers were assured anonymity, the statement said.

At the heart of the Lyme disease controversy is whether the Lyme infection can sometimes be chronic. Both sides agree it can cause long-term problems; however, the infectious disease group holds that what it calls post treatment Lyme syndrome is caused by residual damage from the original infection. The other side says chronic Lyme can be caused by failure of the Lyme bug, Borrelia burgdorferi, to be eradicated in recommended antibiotic courses of two to four weeks.

Patient advocates want the mainstream side to consider emerging evidence of the ability of Lyme to persist — in animals, in different forms in laboratories, and, most recently, in a small study in which an uninfected tick was put on a person treated for Lyme disease and itself became infected.

"How can these panelists be impartial when they have staked their reputations on the position that chronic Lyme does not exist?" said Josh Cutler, co-founder of The Mayday Project, an advocacy group, pointing to six panelists alone who authored the original guidelines. They are among perhaps a dozen that advocates say have significant intellectual and financial conflicts of interest.

In its response to Journal questions, the society's statement said a "majority" of panelists have "no relevant conflicts of interest." But it did not preclude panel changes in response to comments by advocacy groups from as far away as Australia. "The committee is considering that feedback ... and will make adjustments to the project plan and panel accordingly," society officials said.

Toward that end, Lyme patient advocates have been waging a vigorous battle through the media. The MayDay group held a protest April 30 and May 1 outside the disease society's Arlington, Virginia headquarters, while running more than 500 television ads in the Arlington area critical of Lyme care. The group even secured a 90-minute meeting in March with the society president, Dr. Stephen Calderwood, and has had its campaign covered by specialty websites like Medscape, Infectious Diseases: Special Edition, and Pain Medicine News.

At issue is how new Lyme standards will be adopted — and by whom.

'Undisclosed interests'

Raging controversy over Lyme treatment guidelines in large part led the federal Institute of Medicine in 2011 to publish standards for developing medical guidelines that were fair and unbiased. The 2006 Lyme guidelines had been questioned in 2008 by then-Connecticut Attorney General Richard Blumenthal, now a U.S. senator, who alleged panel members had "undisclosed financial interests .... in Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies;" as a result, he said, the panel "improperly ignored or minimized consideration of alternative medical opinion" on chronic Lyme disease. The society fought the charges but agreed to an independent review, which upheld the guidelines in 2010.

The Institute of Medicine said the controversy was "illustrative" of the need for a uniform process across diseases, involving doctors, patients and scientists with diverse viewpoints. Its report made clear that conflicts of interest could lead to bias by, among others, "specialty societies, which might benefit or whose members might gain from guideline recommendations."

Indeed, that is the fear of many Lyme patient advocates, who object to the heavy representation of scientists whose publications show them in favor of existing treatment regimens. Specifically, the panelists include members who:

Authored current Lyme guidelines. Eight of the 30 members participated in writing or consulting on the 2006 treatment regimens that are contested by advocates.

Have led previous reviews. One panel co-chair is among the 2006 authors; another was the lead author of a report that upheld them after the Blumenthal probe. Federal standards stipulate that co-chairs should have no conflicts of interest, while panelists with conflicts should be no more than a minority of members.

Have authored articles undercutting the chronic Lyme concept. Eight panelists, including four original guideline authors, co-authored a 2007 article in the New England Journal of Medicine debunking the existence of chronic Lyme disease. One more joined two original guideline authors to pen a 2014 article rejecting scientific support for chronic Lyme.

Report potential conflicts of interest. In disclosures for panel inclusion, eight members — including a panel co-chair — said they received government or private research grants, including six for studies of Lyme tests; advocates say the panel's endorsement of any test is a coveted prize for manufacturers.

Gave legal assistance. Four panelists reported serving as legal experts or consultants. But the details of their roles are scant and listed, for example, simply as "Lyme-legal." Two reported elsewhere that they testified in Lyme disease malpractice cases in support of the current guidelines.

Although there is overlap among the various groups above, the Poughkeepsie Journal counted at least 13 members who authored, endorsed or reported Lyme-related conflicts of interest. Nonetheless, the panel's plan said there were "no relevant" conflicts, and the panelists were approved.

In its statement to the Journal, society officials wrote, "Panel members who do have conflicts of interest have clearly disclosed those relationships and will be fully transparent moving forward."

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Brianne Radtke, 28, of the Town of Newburgh, was diagnosed with Lyme disease at 16 and still suffers from residual symptoms.(Photo: Alex H.Wagner/Poughkeepsie Journal)

Comments reviewed

In an email, Dr. Paul Lantos, a Duke University researcher appointed co-chair, said, "We're going through the public input, some of which addresses issues that you've raised, and we will have some commentary on that down the road."

Lantos was lead writer of the 2010 review upholding the guidelines and authored the 2014 article rejecting support for chronic Lyme, considered a conflict of interest by some. He said his potential conflicts were reviewed by a separate committee which determines if members are in "concordance with recognized standards."

Lyme patient advocates and selected scientists and physicians fault current treatment guidelines in large part because they endorse diagnosing Lyme through standard tests and the distinctive red rash — and discourage the practice, common in many illnesses, of diagnosing "clinically," or by symptoms alone. Because tests fail early on — which mainstream scientists acknowledge — and the rash does not always occur, such endorsements lead to undiagnosed cases, they believe. Significantly, the 2010 review panel was split on whether to discourage clinical diagnosis.

"This is a disease, if not treated early, people can become devastatingly ill," said Johnson, the Lymedisease.org head and an author of the alternative guidelines.

Kelsey DePue, 20 and a Marist College criminal justice major, knows the dangers of undetected Lyme disease, which she had — along with severe joint pain and unremitting headaches — for perhaps two years before her diagnosis at age 14.

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Kelsey DePue, 20, of Highland, was infected for about two years before her diagnosis with Lyme disease.(Photo: Alex H. Wagner/Poughkeepsie Journal)

"I think a lot of people miss it because I never saw a tick bite mark, I never saw a bulls-eye (rash)," said DePue, who lives in Highland.

Brianne Radtke, 28, a media specialist for a City of Poughkeepsie advertising agency, also went undiagnosed in her early teens when a doctor mistook her symptoms for something else and declined to test for Lyme disease.

Had it been caught, "I wouldn't have the residual infections...I would get sick less often," said Radtke, a Town of Newburgh resident. "It's life-changing to a degree."

'No one's looked'

Advocates say cases like these point up the need for representation on the panel of doctors and researchers who challenge the prevailing view of Lyme disease testing and care. Instead, it features many in favor of it.

"They're asking questions without the right people at the table," said Dr. Elizabeth Maloney, a Minnesota physician and researcher who conducts continuing-education courses on Lyme disease.

She cited publications by panel members in 2014 of summaries of existing research, called systematic reviews, that endorse prior findings and will be used, Maloney and others contend, to bolster the panel's findings. One such study, by Dr. Lantos and two other panel members, concluded that previous findings on various forms of the Lyme pathogen, as the title states in part, "Does Not Support a Role in Chronic Lyme Disease."

"There's no evidence," Maloney said, "because no one's looked." Federal Lyme disease research funding amounts to $23 million a year — half that of West Nile virus, which affects far fewer people — advocates note. Fallon, the Columbia researcher, agreed a dearth of funding may cause existing guidelines to stay in place: "Unfortunately there haven't been sufficient treatment studies done to really allow us to make strong statements regarding guidelines on how to treat," he said.

Dr. Richard Horowitz, a prominent tick-borne disease physician who practices in Hyde Park, has written a book, "Why Can't I Get Better?", on the interplay between Lyme and other tick-borne infections, the inadequacy of tests, and the inflammatory processes that result. "It would have been nice to have someone like myself on the panel," he said.

As for the future, the society statement said it will publish a response to comments on its review plan on its website but it did not say when. "Our goal is to complete a draft of the guidelines within two years," the statement said.